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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

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The Gründler HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.

Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler's HumiCare D900. The heated breathing circuits are used for flow rates greater than 3L/min.

The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

The HumiCare D900 system is a respiratory gas humidifier according to 21 CER §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity.

The HumiCare D900 including heated air tubings is an active heated humidifier which employs a passover humidification via an enhanced surface area for gas/water. The huge gas/water sufface area is resulting in an output of gas with a temperature almost identical to that of the water with a relative humidity of 100%.

The principle HumiCare D900 is to direct the gas mixture from the ventilator's outlet into the humidifier's water chamber via air tubing. There it is heated and humidified by means of heated water. A heated inspiratory tube is used to transport the conditioned gas from the water chamber's outlet to the patient.

Depending on the patient interface an inspiratory tube or inspiratory and expiratory tubes can be used for the humidification with HumiCare D900. The inspiratory limb can further include an antibacterial filter with filter heater to reduce condensation. In order to minimize condensation (rain out), both inspiratory and expiratory air tubing can be actively heated therefore temperature sensors are included in the inspiratory and expiratory air tubing,

The HumiCare D900 system consists of a heater base with external power supply, connector cables, a 30day disposable water chambers, heated tubes (inspiratory), connection tube, antibacterial filter and filter heater. The 30day disposable water chamber and air tubing circuits are intended for single patient use, with the exception of when an antibacterial filter is incorporated into the circuit allowing multi-patient use of the chamber. The HumiCare D900 heater base and filter heater are intended for multi-patient re-use.

The HumiCare D900 is a respiratory gas humidifier. The provided text from the 510(k) summary (K122765) states that various design and verification activities were performed to ensure the device met predetermined acceptance criteria. These tests confirmed that the product met these criteria, specifically highlighting side-by-side testing for humidification performance and resistance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices."

However, specific numerical acceptance criteria or detailed performance reports are not provided in this summary. The summary only generally states that the device met the criteria and was substantially equivalent to predicate devices for "humidification performance" and "resistance of the humidifier."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It also does not define the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or a ground truth established by them for the performance validation of the HumiCare D900. The testing appears to be of a technical/engineering nature, comparing the device's technical specifications and performance against predicate devices and relevant standards.

4. Adjudication Method for the Test Set

Since an expert-based ground truth is not mentioned, there is no adjudication method described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes a medical device (a respiratory gas humidifier) and its engineering and performance validation. It does not involve human readers interpreting data or a multi-reader multi-case comparative effectiveness study in the context of AI assistance.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done in the sense that the device's performance was evaluated against predetermined acceptance criteria and compared to predicate devices. The text states: "All tests confirmed the product met the predetermined acceptance criteria. In particular side-by-side testing demonstrated that the HumiCare D900 essential performance specifications (humidification performance, resistance of the humidifier) are Substantially Equivalent to the predicate devices." This implies that the device (algorithm/system) was tested on its own to demonstrate its functionality and equivalence.

7. The Type of Ground Truth Used

The "ground truth" for the HumiCare D900's performance appears to be based on:

• Engineering specifications and pre-determined acceptance criteria for device functionality.
• The performance characteristics of legally marketed predicate devices, against which the HumiCare D900 was deemed "substantially equivalent."
• Compliance with recognized standards (e.g., ISO 8185:2009 for humidifiers, ISO 10993 series for biocompatibility, IEC 60601-1 for safety).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical device (a humidifier) and not an AI/machine learning model that undergoes training on data.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" is not applicable to this device. Therefore, no ground truth for a training set was established.

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The NeoPAP System is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat newborns and infants, weighing less than 5 kg, with RDS or who are recovering from RDS. (Respiratory Distress Syndrome).

The Children's Medical Ventures LLC NeoPAP System provides nasal CPAP (continuous positive airway pressure) as a non-invasive method of breathing support for infants and newborns with compromised respiratory systems who weigh less than 5 kg.

The NeoPAP System provides CPAP therapy delivered to patient through a nasal cannula or mask. The system has a feature called Baby-Trak which actively regulates pressure at all times by monitoring pressure at patient's nose and adjusting flow from oxygen and air gas supplies using proportional solenoids. The Baby-Trak feature eliminates the need for a closely-fitted patient interface that can damage fragile tissues.

In addition to CPAP mode, the NeoPAP System offers a constant flow mode where the device delivers a fixed flow of humidified air/oxygen mixture through the nasal prongs or mask. There is also a resuscitation mode where the device delivers a fixed flow of unhumidified air/oxygen through the resuscitation port for use with a resuscitation or hyperinflation bag. The percentage of oxygen can be adjusted while in any mode by using a rotary knob on the user interface.

The NeoPAP System alarms when pressure levels or oxygen concentration are above or below alarm limits. The system also detects occlusion, disconnect, and other alarm conditions. The system displays a real-time bar graph that indicates delivered pressure.

The provided document describes the NeoPAP System, a medical device for providing continuous positive airway pressure (CPAP) to newborns and infants. It focuses on demonstrating substantial equivalence to a predicate device (Guardian Neonate CPAP / Humidification System, K040862) after modifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All tests that were created for the modified NeoPAP System had passing results with acceptance criteria successfully met, which demonstrates the safety & effectiveness of the system." However, the specific quantitative acceptance criteria and detailed performance results for each test are not explicitly listed in the provided text. The document primarily focuses on what was tested and the conclusion that criteria were met, rather than presenting the criteria and performance data in a tabular format.

A general summary of some "performance aspects" that are implied to meet criteria through comparison to the predicate device would be:

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